Z-0453-2010

Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.5 x 64MM, spinal implant...

Name: Z-0453-2010 Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.5 x 64MM, spinal implant...
Creator: Stryker Spine
Published: 2009-10-02
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2009-10-02 / Terminated / root cause: design

FDA source

Stryker Spine began a recall of Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.5 x 64MM, spinal implant component on 2009-10-02. The reason FDA records is "Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause the Thor...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0453-2010
Status: Terminated
Initiated: 2009-10-02
Posted: 2009-11-24
Terminated: 2013-01-23
Recalling firm: Howmedica Osteonics Corp
Product: Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.5 x 64MM, spinal implant component
Product code: KWQ Appliance, Fixation, Spinal Intervertebral Body
Reason for recall: Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause the Thor screwdrivers to twist or break at the tip.
Root cause tag: design
FDA root cause: Device Design
Action: Recall notification letters were sent to all Stryker branches, Hospital Risk Management and Surgeons on October 19, 2009 by Federal Express. Questions are to be directed to Tiffani Rogers, Regulatory Compliance Manager at 201-760-8206.
Quantity in commerce: 157
Distribution: Nationwide
Product codes and lots: Catalog number 48036564, all lots

Product code KWQ

K073437Class IIThor Anterior Plating SystemStryker Spine / cleared 2008-02-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)